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目的回顾分析3年来参加卫生部新生儿疾病筛查实验室室间质量评价的反馈结果,总结实验过程中的问题。方法分别采用荧光法和时间分辨荧光免疫分析法(DELFIA)对卫生部临检中心分发的各批次质评样本的苯丙氨酸(Phe)和促甲状腺激素(TSH)值进行检测,对反馈结果进行总结分析。结果3年来共接受卫生部临检中心分发的9批次共计45份质评样本。Phe测定结果偏倚分布范围在-17.39%～25%之间,相对偏倚平均值为7.51%;TSH测定结果偏倚分布范围在-35.29%～22.22%之间,相对偏倚平均值为8.4%;45份质评样本中,1份TSH测定结果失控(偏倚≤-30%),失控率为2.22%(1/45);45份Phe质评样本中,阴性6份,阳性39份,定性判断结果符合率为100%(45/45);45份TSH质评样本中,阴性22份,阳性23份,定性判断结果出现2例假阳性,符合率为95.56%(43/45);每一批次项目评分结果均≥80%,室间质量评价合格。结论参加全国新生儿疾病筛查实验室苯丙氨酸和促甲状腺激素检测室间质量评价,有助于评估实验室的检测能力,及时发现和解决筛查实验过程中存在的问题,从而提高检测质量,减少实验误差,保证筛查结果的准确性。
Objective To review and analyze the feedback results of inter-laboratory quality assessment of newborn disease screening laboratory of Ministry of Health in the past three years and summarize the problems in the experiment. Methods The phenylalanine (Phe) and thyrotropin (TSH) values of each batch of quality evaluation samples distributed by the Clinical Laboratory of Ministry of Health were detected by fluorescence and time-resolved fluorescence immunoassay (DELFIA) The results of the summary analysis. Results In the past three years, a total of 45 batches of quality evaluation samples were obtained from 9 batches distributed by the Clinical Laboratory of the Ministry of Health. The range of bias of Phe was -17.39% ~ 25% and the average of relative bias was 7.51%. The range of bias of TSH was -35.29% ~ 22.22%, and the average of relative bias was 8.4% In the quality evaluation samples, one TSH test result was out of control (deviation≤-30%), and the rate of out of control was 2.22% (1/45). Among 45 samples of Phe quality evaluation, 6 were negative and 39 were positive. The positive rate was 100% (45/45). Among the 45 TSH samples, 22 were negative and 23 were positive. Two false positives were found by qualitative judgment, with a coincidence rate of 95.56% (43/45). Each batch of items Grading results were ≥ 80%, inter room quality evaluation. Conclusion To participate in the National Neonatal Screening Laboratory phenylalanine and thyroid stimulating hormone testing of inter-laboratory quality assessment will help assess the laboratory testing capabilities to detect and solve screening problems in the process of testing to improve the detection Quality, reduce experimental error, to ensure the accuracy of screening results.